Titan Medical Inc (TMDIF)

[BIGKAHUNA57]

Well I'm not saying that I'm 100% happy about managements performance, but was commenting about the FDA requirements. It's not a cut-and-dry process. If the predicate device is daVinci, then there are 10 years of functionality to mimic. That's a tall order in 1 year. And if there was a misunderstanding that SPORT could be FDA approved on a "task oriented performance basis" then the rejection of Suribot was very beneficial as it provided more detail about what is necessary do to get approved.

The pps of this company does reek of manipulation. And I do agree that the cc created more questions than answers. I also agree that the AGM will be very eventful with all of the outstanding questions, and need for further details about the OEM, and financing going forward. It's a hell of a device and again, if there were any flaws or omissions in functionality, we would have heard about it during or after SAGES.

Is it still possible to submit a lesser version for CE mark and begin to sell outside US, sooner than when the OEM partnered version is made available? Or use the OEM version with fewer indications and go for V1.2 when fully completed? Why not sell the OEM version with 2 to 4 main indications, and provide additional indications as V1.2 as a chargeable upgrade? Brings the product before the FDA sooner, and to market quicker. Just a thought.

JMO.

Respectfully,
BK